Pharmacy Law Terms Exam I

Good Moral Character

those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare

Good Standing

means the pharmacist’s personal registration is not currently being sanctioned by the Board

 Preceptor

means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns

Pharmacy Intern

Internship means the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts

licensure by Reciprocity

if you hold a license in one state, you can get a similar license in another state without retaking the main exams required in that state. Taking a law exam might be required as every state has different laws.

When do Mass pharmacist licenses expire?

December 31st

Immunization CE requirment

1 contact hour each calendar year (ACPE approved)

U.S. Pharmacopeial Convention (USP) dates

only physicians allowed in 1820

pharmacists invited in 1840

U.S. Pharmacopeial Convention (USP)

developed list of medicinal drugs with their effects and directions for their used; designed to bring uniformity, promote safety and quality control

General definition of Law

Requirements for human conduct applying to all persons within their jurisdiction

Market failures

▪ Public goods
▪ Externalities
▪ Natural monopolies
▪ Information asymmetry

Public Goods

Necessary and beneficial commodities that private entities will not supply because there is no incentive

Externality

▪ When the production or consumption of a good affects
someone who does not fully consent to the effect
▪ When the costs of the good are not fully incorporated in the price of the good
▪ Example: indiscriminate use of antibiotics

Monopoly

When the fixed costs of providing a good are high, relative to the variable costs of producing the good

ex: patents and market exclusivity for new drugs

Under Federal Law, how many classes of controlled substances are there?

5

Under Mass Law, how many classes of controlled substances are there?

6

Public goods examples

orphan drugs, vaccines

Information Asymmetry

When the consumer is uninformed about the true value of a good

Information Asymmetry examples

prescription only drugs, written consumer information for certain drugs

Limits of the Law

▪ Certain human relationships
▪ De minimis violations
▪ Protecting individual freedoms while preventing harm to others

Sources of Law

▪ U.S. Constitution (No federal or state law may conflict)
▪ Legislatures
▪ Administrative agencies
▪ Courts

Legislatures: Statutory Law

▪ U.S. Congress (federal laws)
▪ State constitutions
▪ State legislatures (state laws)
▪ Political subdivisions (ordinances)

Law Made by Administrative Agencies

Administrative agencies are created by legislatures to administer a body of substantive law.

Law Made by Administrative Agencies: Legislative Function

• Promulgate regulations
  ▪ Regulations interpret, define, and add detail to statutes

• Regulations enacted via notice and comment rulemaking

• Validity tests of a regulation:
  ▪ Within scope of board’s authority
  ▪ Based on statutory authority
  ▪ Reasonable relationship to public health, safety, and
  welfare

Law Made by Administrative Agencies: Judicial Function

▪ Render decisions pursuant to “hearings” resembling
court proceedings
▪ Decisions subject to judicial review
▪ The court will review record to determine if decision was based on substantial evidence.

De novo:

If substantial evidence is lacking, court will conduct an entirely new trial

Federal Agencies

Regulations published in Federal Register (Fed. Reg.)
and Code of Federal Regulations (CFR)

Federal Register

daily publication of proposed and final regulations and notices

CFR

compilation of final regulations divided and indexed by subject matter

Common Law

refers to judicial opinions; adopted from the English judicial system

Judicial opinions:

• decisions of the court

• Enforceable as law

• Binding on lower courts in the same jurisdiction

Stare decisis

▪ Opinions are binding on lower courts in the same
jurisdiction and serve as precedent.
▪ Reasons for deviating from precedent include factual
distinctions and changing times or circumstances.

Relationship of Common Law to Statutory Law

Courts often must interpret the meaning and application of statutes.

Principles of interpretation include:

▪ Determining legislative intent, if possible
▪ Ordinary meaning of words
▪ Due process rights of the individual

Criminal: government v. private party

Charged with a crime as prohibited by a statute and subject to penalties specified by statute
▪ Objectives: deter, punish, rehabilitate

Civil: private party v. private party

May be based upon statute or common law legal rights
▪ Objective: compensation to injured party

Administrative: agency v. private party

Disciplinary determination, which may include warning,
fines, licensure revocation or suspension, probation

The Legislative Process: Federal Level

• Congress
  ▪ Senate
  ▪ House of Representatives

• The sponsor of a bill must be a legislator.

• The bill is sent to appropriate congressional committee.
  ▪ Holds hearings, conducts investigations
  ▪ Determines whether bill will go to Senate or House floor

FDA *

Food and Drug Administration

DEA *

Drug Enforcement Administration

The Legislative Process: State Level

▪ State legislatures generally modeled after Congress
▪ Legislative history generally harder to determine
because there are fewer written records of committee
hearings and reports

U.S. Supreme Court

▪ Highest U.S. court. Nine justices; lifetime appointment
▪ Original jurisdiction only in cases involving ambassadors, other public ministers, consuls, and when a state is a party
▪ Other cases heard by writ of certiorari

Court of appeals

12 judicial circuits and courts; primarily hear appeals

District courts

Jurisdiction primarily based on whether there is a federal
law or constitutional issue; diversity citizenship; or if a state
or the U.S. is a party

Civil Court Procedures: Selection of Court

State court likely unless:
▪ Federal issue is involved
▪ Parties are from different states

Plaintiff

person bringing the action

defendant

person action is brought against

Plaintiff must prove “standing” …

▪ The challenged conduct has caused the plaintiff injury.
▪ There is a legally protectable interest.

Civil Court Procedures: Statute of Limitations

Limits the period of time in which a case can be filed

Summons

issued by court notifying defendant of suit and commanding defendant to file an answer

Complaint

contains all material facts of case and remedy requested

Answer

admitting to or denying allegations
▪ Default judgment if answer not filed

Civil Court Procedures: Discovery

Pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely

Deposition

out-of-court testimony by a witness under oath

Voir dire examination

the questioning by each side of potential jurors

Witnesses

▪ May be subject to subpoena, an order to appear in court
▪ Failure to appear may result in contempt of court.

Expert witnesses

Called when the factual subject matter is beyond the scope of jurors

Motion for summary judgment:

one party attempts to convince the judge that the claims of the other side have no merit, even if correct

Motion for directed verdict:

after the introduction of evidence, one party alleges that the other lacks
sufficient evidence.

Objections

attempt to restrict the introduction of evidence or testimony; might constitute issues of law
for appeal

Judgment notwithstanding the verdict (NOV):

the judge may rule contrary to the jury if the jury clearly reached the wrong verdict

Civil Court Procedures: Verdict and Appeal

▪ A mistrial may be granted if a major error or violation of law or procedure occurred during the trial.
▪ Either party may appeal the final verdict based on an error of law.
▪ For an appeal, attorneys submit a “brief” to the court, citing the legal principles and precedent involved and why the lower court erred.

Indictments

issued by a grand jury when it determines that enough evidence exists for an arrest
and trial

If arrested, the judge must determine at a _____ if there is enough probable cause for an arrest; if so, the defendant must enter a plea at an arraignment.

preliminary hearing

The parties may agree to a ____ in which
the defendant agrees to a lesser charge rather than
face a trial

plea bargain

Burden of proof is ____ rather than a “preponderance of the evidence” as in
a civil trial.

beyond a reasonable doubt

Federal Versus State Law

▪ When federal and state law conflict, federal law will preempt state law under the Supremacy Clause of the U.S. Constitution.
▪ Conflicts generally exist when state law is less strict than federal law.
▪ Federal authority to regulate drugs generally arises from the Interstate Commerce Clause of the U.S. Constitution.

State authority to regulate generally derives from the ____ to the U.S. Constitution and under its inherent police powers.

Tenth Amendment

State laws must bear a reasonable relationship to the ______-

public health, safety, and welfare.

a Mass Rph may not earn more than eight contact hours for continuing education in a calendar day for credit for MA CE

true